Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

University of Washington

Status and phase

Completed

Phase 2

Conditions

Fibromyalgia

Chronic Pain

Depression

Treatments

Device: Sham rTMS

Device: rTMS

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00524420

06-2407-D 01 (Other Identifier)

32656-D

R21AR053963 (U.S. NIH Grant/Contract)

1R21AR053963-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of time, chronic pain persists and can continue for months and even years. Repetitive transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the brain and can affect brain activity. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing chronic widespread pain in women.

Full description

Chronic widespread pain is characterized by musculoskeletal pain that lasts for at least 3 months, pain above and below the waist, pain on both the right and left sides, and pain in the head, neck, spine, or back. In addition to fatigue, chronic widespread pain is a hallmark feature of fibromyalgia. Significant physical and emotional effects usually accompany chronic widespread pain and fibromyalgia, making the development of effective treatments a priority. rTMS involves a neurophysiologic technique that directs a current into the brain by using a magnetic field to pass the scalp and skull safely and painlessly. Stimuli are applied to the same brain area several times per second during several consecutive seconds. rTMS has been found to be effective for treating certain types of chronic pain. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing bodily pain associated with chronic widespread pain and/or fibromyalgia in women.

Participants in this study will undergo a diagnostic interview, physical and neurological exam, electrocardiogram, magnetic resonance imaging, and blood and urine collection for screening purposes. Eligible participants will then be randomly assigned to receive either rTMS treatment or sham rTMS treatment. One-hour daily treatment sessions will occur over 15 days. After every five treatment sessions, participants will be interviewed about their pain and depression symptoms, and they will fill out questionnaires about pain, depression, fatigue, sleep, and exercise. Participants will also undergo pain threshold and tolerance testing of their right thumb. On a daily basis, participants will rate their level of pain using a 0 to 20 scale. Follow-up evaluations will occur 1, 4, and 12 weeks after treatment and will include a repeat interview and testing. After the follow-up evaluations, any participants who did not respond to the sham treatment will be offered a series of 15 real rTMS treatment sessions.

Enrollment

19 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of chronic widespread pain as defined by the 1990 American College of Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain above and below the waist; pain on both right and left sides; pain at one axial site (e.g., head, neck, spine, or back)
Willing to remain on a stable medical regimen during the entire 6-week course of Phase 1 treatment and 8 weeks prior to rTMS treatment
Willing to undergo random assignment and able to attend treatment sessions
Willing to remain on a stable psychotherapy regimen if currently receiving psychotherapy that has been ongoing for at least 3 months prior to study entry

Exclusion criteria

Unable to maintain treatment as usual at stable doses for any medical or psychiatric conditions for 8 weeks prior to and during the study
Another medical condition associated with significant pain (e.g., diabetic neuropathy, systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative joint disease)
Any condition that might increase the risk of seizures from TMS
History of a seizure disorder or family history of a seizure disorder
Previous use of TMS
Involvement in litigation or disability that is related to fibromyalgia, chronic widespread pain, or depression
Current use of proconvulsant medications (e.g., bupropion)
Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g., aneurysm clips, pacemakers, neurostimulators)
History of head injury associated with loss of consciousness for more than 15 minutes, brain surgery, or lithium toxicity
History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic disorder, or post-traumatic stress disorder
Current substance abuse or dependence
Active suicidal intent or plan
Severe claustrophobia that would prevent MRI
Major depression with psychotic features or a current major depressive episode lasting longer than 5 years
Pregnant